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Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial

BACKGROUND: Up to 95% of people entering treatment for use of alcohol or other drugs (AOD) smoke tobacco. Smokers receiving treatment for AOD use are interested in quitting and make quit attempts, but relapse is more common and rapid compared with the general population of smokers. New ways to addre...

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Autores principales: Guillaumier, Ashleigh, Manning, Victoria, Wynne, Olivia, Gartner, Coral, Borland, Ron, Baker, Amanda L., Segan, Catherine J., Skelton, Eliza, Moore, Lyndell, Bathish, Ramez, Lubman, Dan I., Bonevski, Billie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6090830/
https://www.ncbi.nlm.nih.gov/pubmed/30071863
http://dx.doi.org/10.1186/s13063-018-2786-1
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author Guillaumier, Ashleigh
Manning, Victoria
Wynne, Olivia
Gartner, Coral
Borland, Ron
Baker, Amanda L.
Segan, Catherine J.
Skelton, Eliza
Moore, Lyndell
Bathish, Ramez
Lubman, Dan I.
Bonevski, Billie
author_facet Guillaumier, Ashleigh
Manning, Victoria
Wynne, Olivia
Gartner, Coral
Borland, Ron
Baker, Amanda L.
Segan, Catherine J.
Skelton, Eliza
Moore, Lyndell
Bathish, Ramez
Lubman, Dan I.
Bonevski, Billie
author_sort Guillaumier, Ashleigh
collection PubMed
description BACKGROUND: Up to 95% of people entering treatment for use of alcohol or other drugs (AOD) smoke tobacco. Smokers receiving treatment for AOD use are interested in quitting and make quit attempts, but relapse is more common and rapid compared with the general population of smokers. New ways to address smoking in this population are needed. Electronic nicotine devices (ENDs) or electronic cigarettes hold significant potential as both cessation aids and harm reduction support. This study focuses on the potential of ENDs to facilitate smoking cessation and to sustain it in the medium term among people in treatment for AOD use. The aim of this trial is to explore the effectiveness, feasibility and acceptability of ENDs for smoking cessation compared with combination nicotine replacement therapy (NRT) for clients after discharge from a smoke-free AOD residential withdrawal service. METHODS/DESIGN: The study is a pragmatic randomised controlled trial. In total, 100 participants will be recruited following admission to a smoke-free residential withdrawal service in Melbourne, Australia. Participants will complete a baseline survey and be randomised to either the END group (n = 50) or the NRT group (n = 50) prior to discharge. Both groups will receive telephone counselling support from quitline. Follow-up measures will be assessed at 6 and 12 weeks following discharge. The primary outcome is continuous abstinence from smoking at 12 weeks post discharge. Secondary outcomes include: 7-day point prevalence from smoking, point prevalence abstinence from all nicotine (including NRT and ENDs), cravings and withdrawal, time to relapse, and treatment adherence (use of NRT, ENDs and quitline). DISCUSSION: This is the first randomised controlled trial to assess the effectiveness and acceptability of ENDs within a population dependent on AOD, a priority group with very high levels of smoking. The research will test a model of how to incorporate novel smoking cessation support into a period of high treatment receptiveness. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12617000849392. Registered on 8 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2786-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-60908302018-08-17 Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial Guillaumier, Ashleigh Manning, Victoria Wynne, Olivia Gartner, Coral Borland, Ron Baker, Amanda L. Segan, Catherine J. Skelton, Eliza Moore, Lyndell Bathish, Ramez Lubman, Dan I. Bonevski, Billie Trials Study Protocol BACKGROUND: Up to 95% of people entering treatment for use of alcohol or other drugs (AOD) smoke tobacco. Smokers receiving treatment for AOD use are interested in quitting and make quit attempts, but relapse is more common and rapid compared with the general population of smokers. New ways to address smoking in this population are needed. Electronic nicotine devices (ENDs) or electronic cigarettes hold significant potential as both cessation aids and harm reduction support. This study focuses on the potential of ENDs to facilitate smoking cessation and to sustain it in the medium term among people in treatment for AOD use. The aim of this trial is to explore the effectiveness, feasibility and acceptability of ENDs for smoking cessation compared with combination nicotine replacement therapy (NRT) for clients after discharge from a smoke-free AOD residential withdrawal service. METHODS/DESIGN: The study is a pragmatic randomised controlled trial. In total, 100 participants will be recruited following admission to a smoke-free residential withdrawal service in Melbourne, Australia. Participants will complete a baseline survey and be randomised to either the END group (n = 50) or the NRT group (n = 50) prior to discharge. Both groups will receive telephone counselling support from quitline. Follow-up measures will be assessed at 6 and 12 weeks following discharge. The primary outcome is continuous abstinence from smoking at 12 weeks post discharge. Secondary outcomes include: 7-day point prevalence from smoking, point prevalence abstinence from all nicotine (including NRT and ENDs), cravings and withdrawal, time to relapse, and treatment adherence (use of NRT, ENDs and quitline). DISCUSSION: This is the first randomised controlled trial to assess the effectiveness and acceptability of ENDs within a population dependent on AOD, a priority group with very high levels of smoking. The research will test a model of how to incorporate novel smoking cessation support into a period of high treatment receptiveness. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry, ACTRN12617000849392. Registered on 8 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2786-1) contains supplementary material, which is available to authorized users. BioMed Central 2018-08-02 /pmc/articles/PMC6090830/ /pubmed/30071863 http://dx.doi.org/10.1186/s13063-018-2786-1 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Guillaumier, Ashleigh
Manning, Victoria
Wynne, Olivia
Gartner, Coral
Borland, Ron
Baker, Amanda L.
Segan, Catherine J.
Skelton, Eliza
Moore, Lyndell
Bathish, Ramez
Lubman, Dan I.
Bonevski, Billie
Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
title Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
title_full Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
title_fullStr Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
title_full_unstemmed Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
title_short Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
title_sort electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6090830/
https://www.ncbi.nlm.nih.gov/pubmed/30071863
http://dx.doi.org/10.1186/s13063-018-2786-1
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